China NMPA Drug Inspection - Jining Vasculitis Hospital - Yiqi Tongmai Capsules

The Shandong Provincial Food and Drug Administration announced on February 8, 2018 (published November 18, 2019) findings from inspections of medical institution preparations. Several drug testing institutions, including Zibo Municipal Institute for Food and Drug Control, identified nine batches of products from eight medical institutions as substandard. Key issues included contamination in preparations such as Lianqiao Baidu Pills and Calamine Lotion, manufactured by institutions including Zibo Municipal Traditional Chinese Medicine Hospital and Jining Municipal Institute of Dermatology and Venereology. Additionally, other products like Yiqi Tongmai Capsules and Pingxiao Baoshi Pills exhibited substandard quality, specifically concerning their total active ingredient amounts, produced by entities such as Jining Vascular Disease Hospital and Tai'an Second Traditional Chinese Medicine Hospital. Operating under the provincial regulatory framework, the relevant municipal food and drug administration bureaus initiated immediate control measures. These included sealing, seizing, and suspending sales of the affected products. Furthermore, investigations were launched into the involved medical institutions to ensure compliance with relevant laws and regulations. The authorities mandated enhanced daily supervision, requiring institutions to thoroughly investigate the root causes of these deficiencies, develop and implement comprehensive corrective actions, and mitigate future risks to patient safety and product quality.